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A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

NCT02066415•Amgen

View on ClinicalTrials.gov

Summary

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Detailed Description

This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy. Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
•History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
•≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
•Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria

•History of cluster headache or hemiplegic migraine headache
•Unable to differentiate migraine from other headaches
•Failed \> 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
•Received botulinum toxinin head or neck region within 4 months prior to screening.
•Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

Locations (74)

Research Site

La Jolla, California, United States

Research Site

Newport Beach, California, United States

Research Site

San Francisco, California, United States

Research Site

Santa Monica, California, United States

Research Site

Sherman Oaks, California, United States

Research Site

Stanford, California, United States

Research Site

Stamford, Connecticut, United States

Research Site

Jacksonville, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Palm Beach Gardens, Florida, United States

Key Dates

Start Date

March 5, 2014

Primary Completion Date

February 24, 2016

Completion Date

April 28, 2016

Last Updated

October 12, 2022

Enrollment

667

ACTUAL participants

Conditions

Treatment for Prevention of Chronic Migraine

Interventions

Erenumab

BIOLOGICAL

Placebo

DRUG